510(k) Report

FDA applicant

Cui Corp.

Santa Barbara, CA7 decisions1990–19910 recalls

FDA records 7 decisions for Cui Corp. (Santa Barbara, CA) from 1990 to 1991: 7 510(k) clearances. Most are in product codes LZK (Implant, Malar) and FZE (Prosthesis, Nose, Internal). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Cui Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cui Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cui Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cui Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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